A Phase 2 interventional study of secukinumab 150 mg (2 injections per dose in Pyoderma Gangrenosum, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
The purpose of this research study is to find out what effects (good and bad) secukinumab has on the subject and their pyoderma gangrenosum.
Secukinumab is a type of medicine called human monoclonal antibodies. Monoclonal antibodies are proteins that recognize and attach to other specific proteins (in this case, immune system hormones called "cytokines") that your body produces. The cytokine (a "messenger" protein in the body) that secukinumab binds to and reduces the activity of is a naturally occurring cytokine called interleukin-17A (IL-17A). IL-17A is believed to be partly responsible for inflammation (pain, swelling, redness), and researchers believe that IL-17A may cause symptoms PG.
This is a prospective, single center, Phase IIa study of secukinumab in the treatment of subjects diagnosed with PG. Subjects will be evaluated at Screening, Baseline (week 0), Week 1, Week 2, Week 3, Week 4, and then every 4 weeks for 24 weeks. The total duration of treatment is up to 20 weeks. Subjects may be treated for shorter durations if the lesions clear prior to week 20. Subjects will have a follow-up visit at 24 weeks, or 4 weeks after the last dose of study drug. Subjects will also have standard of care wound dressings done at each visit. Subjects will be given 300 mg of secukinumab SQ at week 0, 1, 2, 3, and 4, followed by injections every 4 weeks, for up to 20 weeks. Subjects may receive a dose increase at week 16 (if there is not at least a 25% reduction in target lesion size) to 300 mg every 2 weeks.
36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.
Browse Pyoderma Gangrenosum studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
a. Diagnosis requires both major criteria and at least two minor criteria i. Major criteria
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 s.c. secukinumab 150 mg injections
Drug: secukinumab 150 mg (2 injections per dose
secukinumab 150 mg (2 injections per dose
Also known as: secukinumab
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Screening visit
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Screening visit to Baseline visit.
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Baseline visit to Week 2.
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from week 2 to week 4.
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 4 to week 8.
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 8 to week 12.
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 12 to week 16.
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 16 to week 20.
Efficacy - Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 20 to week 24.
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Baseline.
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Baseline to week 2.
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 2 to Week 4.
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 4 to Week 8. .
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 8 to Week 12.
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 12 to Week 16.
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 16 to Week 20.
Efficacy - Subject Global Assessment (SGA)
Subject Global Assessment (SGA) as measured by a 7 point scale anchored by 'Completely Clear" and "Worse"
Time frame: Change from Week 20 to Week 24.
Efficacy - Ulcer Lesion Assessment PG Target Lesion
Number of subjects achieving 50% improvement in PG lesion size
Time frame: Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
Efficacy - Ulcer Lesion Assessment PG Target Lesion
Number of subjects achieving resolution of inflammation with an erythema score of 0 and a border elevation of 0 on five point scales of none to very severe
Time frame: Change from Screening visit, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2021; primary completion for Dec 2021, 7 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Secukinumab
Wake Forest University Health Sciences →